Tube Fixing Device

Abstract

A tube fixation device is provided, the tube fixation device including an upper clamp having an upper surface and a lower surface, a lower clamp having an upper surface and a lower surface, and a hinge located between the upper clamp and the lower clamp to define a tube insertion area. Further, a ratio of a length of an upper surface of the upper clamp to a length of a lower surface of the lower clamp is in a range of about 0.95 to about 1.20. Without intending to be limited by any particular theory, the inventors have found that such a ratio allows the tube fixation device to accommodate a variety of tube sizes without restricting fluid flow, while at the same time ensuring that the tube does not fall out.

Description

[Technical field]

[0001] Related Applications This application claims priority to U.S. Provisional Patent Application No. 63 / 327,400, filed April 5, 2022, the entire contents of which are incorporated herein by reference.

[0002] The present invention relates generally to a tube securing device for securing a tube, such as a feeding tube, catheter, IV tube, etc., to a patient's skin to prevent the feeding tube from falling out. [Background technology]

[0003] Tubes are used in a variety of medical applications to deliver fluids or remove fluids from patients. For example, feeding tubes, such as nasogastric feeding tubes, are used to provide nutritional support to critically ill patients. However, nasogastric feeding tubes can easily fall out due to the patient's mental state, transportation, or position changes. Studies suggest that about 40% to about 62% of nasogastric feeding tubes fall out at some point during use. Tube dislodgment can lead to delays in enteral nutrition, increased risk of aspiration, or malpositioning of the feeding tube at the time of replacement, which can lead to increased health care costs and increased time spent replacing the tube. Further complicating the issue is that there are numerous sizes of nasogastric feeding tubes on the market depending on the manufacturer, and the fixation devices currently used to prevent dislodgment of nasogastric feeding tubes on the market do not fit all sizes and brands of nasogastric feeding tubes, and typically only function adequately to secure nasogastric feeding tubes having a certain outer diameter. This leads to additional problems for healthcare providers in ensuring that nasoenteric feeding tubes are securely placed to provide optimal patient benefit. In other words, currently available standard clamp configurations are designed to accommodate only one specific size nasoenteric feeding tube.

[0004] Therefore, a need exists for a tube securing device that can accommodate tubes having a variety of outside diameters in a safe manner to prevent dislodgment of the tube during use. Summary of the Invention

[0005] The objects and advantages of the present invention will be set forth in part in the description which follows, or may be obvious from the description, or may be learned by practice of the invention.

[0006] In one particular embodiment, the present disclosure is directed to a tube fixation device, the tube fixation device including an upper clamp having an upper surface and a lower surface, a lower clamp having an upper surface and a lower surface, and a hinge located between the upper clamp and the lower clamp to define a tube insertion area, further comprising a ratio of a length of the upper surface of the upper clamp to a length of a lower surface of the lower clamp ranging from about 0.95 to about 1.20.

[0007] In another embodiment, the length of the top surface of the upper clamp can range from about 1.25 millimeters to about 1.7 millimeters.

[0008] In yet another embodiment, the length of the lower surface of the lower clamp can range from about 1.2 millimeters to about 1.6 millimeters.

[0009] In yet another embodiment, the upper surface of the upper clamp and the lower surface of the lower clamp can be slidably engaged when the upper clamp is pressed toward the lower clamp to secure the tube within the tube insertion area. Additionally, the upper surface of the upper clamp and the lower surface of the lower clamp can form an angle with respect to each other ranging from about 0° to about 25° when slidably engaged to accommodate a wide range of tube sizes.

[0010] In an additional embodiment, the tube securement device can include a protrusion extending from a base of the tube securement device adjacent the hinge.

[0011] In another embodiment, the tube insertion region can have a radius, and the ratio of the radius of the tube insertion region to the outer diameter of the tube to be inserted into the tube insertion region can range from about 1:1 to about 1:3.

[0012] In another embodiment, at least one protrusion may extend from the lower surface of the upper clamp.

[0013] In yet another embodiment, the top surface of the lower clamp can include a first indentation on a first edge, a second indentation on a second edge, and a raised portion defined therebetween.

[0014] In yet another embodiment, the upper surface of the upper clamp and the lower surface of the upper clamp can define a trapezoidal shape where the upper and lower surfaces meet.

[0015] In an additional embodiment, the tube clamping device can include an intermediate layer having an upper surface and a lower surface, and the upper surface of the intermediate layer can be attached to the lower surface of the base of the tube clamping device.

[0016] Additionally, the tube fixation device can also include a nonwoven layer having an upper surface and a lower surface, and the upper surface of the nonwoven layer can be attached to the lower surface of the intermediate layer.

[0017] Additionally, the tube securement device can include an adhesive layer having an upper surface and a lower surface, the upper surface of the adhesive layer can be attached to the lower surface of the nonwoven layer, and the lower surface of the adhesive layer can include an adhesive and can be attached to a removable release liner.

[0018] In another embodiment, the tube securement device can secure tubing having a size of 6 French, 8 French, 10 French, 12 French, or 14 French. Additionally, the tubing can be formed from silicone, polyurethane, polyvinyl chloride, or combinations thereof.

[0019] In another embodiment, the tube securement device may be configured to secure a feeding tube, such as a nasoenteric feeding tube.

[0020] These and other features, aspects, and advantages of the present invention will become better understood with reference to the following description and appended claims. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention.

[0021] A full and enabling disclosure of the present invention, including the best mode thereof, directed to one of ordinary skill in the art, is set forth in this specification, which makes reference to the accompanying drawings. [Brief description of the drawings]

[0022] [Figure 1] FIG. 1 is a side perspective view of one embodiment of a tube fixation device of the present disclosure. [Diagram 2] FIG. 1 is a front perspective view of one embodiment of a tube fixation device of the present disclosure. [Diagram 3] FIG. 1 is a rear perspective view of one embodiment of a tube fixation device of the present disclosure. [Figure 4] FIG. 1 is a rear view of one embodiment of a tube fixation device of the present disclosure. [Diagram 5] FIG. 13 is a front perspective view of another embodiment of a tube fixation device of the present disclosure. [Figure 6] FIG. 13 is a side view of another embodiment of a tube fixation device of the present disclosure. [Figure 7] FIG. 1 is a side view of a tube securement device of the present disclosure secured around a feeding tube having a first outer diameter. [Figure 8] FIG. 8 is a side view of a tube securement device of the present disclosure secured around a feeding tube having a second, larger outer diameter compared to the feeding tube of FIG. [Figure 9] FIG. 2 is a front perspective view of the tube fixation device of the present disclosure showing the various layers used to attach the tube fixation device to the surface of a patient's skin. [Figure 10] 1 illustrates a tube securement device in use for securing a nasogastric feeding tube to a patient's skin after a portion of the tube has been inserted into the patient's nostril. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] Reference will now be made in detail to one or more embodiments of the invention, examples of the invention, examples of which are illustrated in the drawings. Each example and embodiment is provided by way of explanation of the invention, and is not meant to limit the invention. For example, features illustrated or described as part of one embodiment can be used with another embodiment to yield still further embodiments. It is intended that the present invention include these and other modifications and variations as falling within the scope and spirit of the invention.

[0024] As used herein, the terms "about," "approximately," or "generally," when used to modify a value, indicate that the value may be increased or decreased by 5% and still fall within the scope of the disclosed embodiments. Furthermore, when multiple ranges are provided, any combination of the minimum and maximum values ​​described in the multiple ranges is contemplated by the present invention. For example, when the ranges "about 20% to about 80%" and "about 30% to about 70%" are described, the ranges "about 20% to about 70%" or "about 30% to about 80%" are also contemplated by the present invention.

[0025] Generally speaking, the present invention is directed to a tube fixation device that includes two clamps (e.g., an upper clamp and a lower clamp) having surfaces that slide against one another to accommodate various sizes of feeding tubes (e.g., feeding tubes available from Cardinal, Corflo, NeoMed (Avanos), and Medicina). The two clamping surfaces contact and slide against one another to accommodate various tube sizes, and the lengths of each surface provide a specific ratio that allows for secure clamping of various tube sizes without unduly restricting the flow of the tube, as discussed in more detail below. Furthermore, in some instances, the surfaces form an angle of about 25° or less with one another, and in some embodiments may be generally parallel to one another (e.g., the surfaces may form an angle of about 0° with one another).

[0026] In one particular embodiment, the tube fixation device includes an upper clamp having an upper surface and a lower surface, a lower clamp having an upper surface and a lower surface, and a hinge located between the upper clamp and the lower clamp to define a tube insertion area. Further, the ratio of the length of the upper surface of the upper clamp to the length of the lower surface of the lower clamp ranges from about 0.95 to about 1.20. Without intending to be limited by any particular theory, the inventors have found that such a ratio allows the tube fixation device to accommodate a variety of feeding tube sizes without restricting the flow of nutrients through the feeding tube, while at the same time ensuring that the feeding tube does not fall out.

[0027] 1 is a side perspective view of one embodiment of a tube clamping device 100 of the present disclosure. The tube clamping device 100 includes an upper clamp 104, a lower clamp 106, and a hinge 112 located between the upper clamp 104 and the lower clamp 106 to define a tube insertion area 102. The tube insertion area 102 has a radius r 1 and is configured to receive the tube 140 (see FIGS. 7, 8, and 10). 1 may range from about 1.3 mm to about 3.3 mm, e.g., about 1.4 mm to about 3.2 mm, e.g., about 1.5 mm to about 3.1 mm, to accommodate various tube sizes while securing the tube, preventing the tube from falling out, and at the same time not unduly restricting flow through the tube. Once the tube 140 is inserted into the tube insertion area 102, the upper clamp 104 and the lower clamp 106 are engaged at their respective upper and lower surfaces 108 and 110 to secure the tube 140 within the tube insertion area 102 and prevent the tube 140 from falling out. In addition, the protrusion 114 on the base 130 of the tube securing device 100 also serves to hold the tube 140 in place within the tube insertion area 102.

[0028] As shown, the upper surface 108 of the upper clamp 104 has a length L 1 and the lower surface 110 of the lower clamp 106 has a length L 2 The length L of the upper surface 108 of the upper clamp 104 1 The length L of the lower surface 110 of the lower clamp 106 2 The particular lengths and ratios of the length L of the upper surface 108 of the upper clamp 104 are specifically controlled to allow the tube fixation device 100 to expand and contract to accommodate various tube sizes while remaining fixed without unduly restricting the flow of the tube. 1 The length L2 of the lower surface 110 of the lower clamp 106 may range from about 1.2 mm to about 1.6 mm, for example, from about 1.25 mm to about 1.7 mm, for example, from about 1.3 mm to about 1.6 mm, for example, from about 1.35 mm to about 1.55 mm. Meanwhile, the length L3 of the lower surface 110 of the lower clamp 106 may range from about 1.2 mm to about 1.6 mm, for example, from about 1.25 mm to about 1.55 mm, for example, from about 1.3 mm to about 1.5 mm. Furthermore, the length L4 of the upper surface 108 of the upper clamp 104 may range from about 1.2 mm to about 1.6 mm, for example, from about 1.25 mm to about 1.55 mm, for example, from about 1.3 mm to about 1.5 mm. 1 The length L of the lower surface 110 of the lower clamp 106 2 may be in the range of about 0.95 to 1.20, such as about 0.96 to about 1.15, for example, about 0.97 to about 1.10.

[0029] 2-4, there are shown other features that may be incorporated into the upper clamp 104 and the lower clamp 106 to reduce friction between the two clamps when the tube fixation device 100 is clamped or depressed to engage the upper surface 108 of the upper clamp 104 with the lower surface 110 of the lower clamp 106 to secure the tube within the tube insertion area 102 upon deflection of the hinge 112 as the upper and lower clamps 104 and 106 are slidably engaged. Specifically, because the lower surface 126 of the upper clamp 104 must move past the upper surface 128 of the lower clamp 106 to allow the upper surface 108 of the upper clamp 104 to contact and slide against the lower surface 110 of the lower clamp 106, the lower surface 126 of the upper clamp 104 may include one or more protrusions 124 or other forms of texturing, bumps, etc., to reduce surface friction.

[0030] Additionally, the upper surface 128 of the lower clamp 106 may have a non-planar geometry to further help reduce friction between the lower surface 126 of the upper clamp 104 and the upper surface 128 of the lower clamp 106 when the tube fixation device 100 is pressed or clamped in the upper clamp 104 so that the upper surface 108 of the upper clamp 104 can move past the upper surface 128 to allow the upper surface 108 of the upper clamp 104 to contact and slide against the lower surface 110 of the lower clamp 106. For example, the lower clamp 106 may include a first indentation 116 on the first edge 120, a second indentation 118 on the second edge 122, and a raised portion 132 defined therebetween to create multiple surface levels to help reduce friction when the upper clamp 104 is pressed or clamped to engage the lower clamp 106.

[0031] 5 and 6, another feature is the geometry of the upper clamp 104 that may be included in the tube securing device 100 to reduce friction and improve ease of sliding of the upper clamp 104 against the lower clamp 106. As shown in FIGS. 5 and 6, the upper surface 108 of the upper clamp 104 and the lower surface 126 of the upper clamp 104 may define a trapezoidal shape 134 where the upper surface 108 and the lower surface 126 meet, and the trapezoidal shape 134 may be the only portion of the upper clamp 104 that contacts the leading edge 135 of the lower clamp 106 when the upper clamp 104 is being depressed or clamped such that the upper surface 108 of the upper clamp 104 may eventually engage the lower surface 110 of the lower clamp 106 to effectively secure the tube in place.

[0032] 7 and 8 show how the tube 140 is secured to the tube securing device 100 of the present disclosure. Specifically, FIG. 7 is a side view of the tube securing device 100 of the present disclosure secured around a feeding tube 140 having a first outer diameter OD, while FIG. 8 is a side view of the tube securing device 100 of the present disclosure secured around a feeding tube 140 having a second larger outer diameter OD compared to the feeding tube 140 of FIG. 7. Generally, the lower surface 110 of the lower clamp 106 contacts the upper surface 108 of the upper clamp 104 after the upper clamp 104 is pressed or clamped to secure the tube 140 inserted in the tube insertion area 102. Depending on the outer diameter OD of the tube 140, an angle α is formed between the upper surface 108 of the upper clamp 104 and the lower surface 110 of the lower clamp 106. 7 and 8, when the outer diameter OD of the tube 140 is larger, the angle α is smaller than when a tube 140 having a smaller outer diameter 140 is used (e.g., the upper surface 108 of the upper clamp 104 and the lower surface 110 of the lower clamp 106 form an angle of about 0° and are generally parallel). In any case, the upper surface 108 of the upper clamp 104 and the lower surface 110 of the lower clamp 106 can form an angle α in the range of about 0° to about 25°, e.g., about 0° to about 15°, e.g., about 0° to about 7.5°, with respect to each other when they slidably engage to secure the tube 140 to the tube insertion region 102 of the tube fixation device 100.

[0033] In addition, the radius r 1The ratio of the diameter of the tube 140 to the outer diameter OD can range from about 1:1 to about 1:3, e.g., from about 1:1.1 to about 1:2, e.g., from about 1:1.2 to about 1:1.5, and the inventors have found that such ratios ensure that the tube 140 is properly secured within the tube retainer 100 without overly restricting flow. For example, based on the ratios described above, the use of a force of about 3 Newtons or more is required to pull the tube 140 through the tube retainer 100. Furthermore, the flow rate through the tube 140 secured within the tube retainer 100 (e.g., a secured single lumen or a large lumen of a dual lumen tube) is at least 70% of the reference flow rate when tested according to ISO 20695 Appendix E, if the ratio ranges described above are maintained.

[0034] 9, various layers are shown that may be used to attach the tube securement device 100 to the patient's skin 160 (e.g., the patient's face or cheek). For example, the tube securement device may include an intermediate layer 138, which may be a foam layer in some embodiments. As shown, an upper surface 142 of the intermediate layer intermediate 138 may be attached to a lower surface 136 of the base 130. The intermediate layer 138 may provide additional support and cushioning to allow optimal placement of the tube securement device 100 as well as flexing and movement with the patient's movements. Additionally, a nonwoven layer 146 may also be included. An upper surface 148 of the nonwoven layer 146 may be attached to a lower surface 144 of the intermediate layer 138. Additionally, a lower surface 150 of the nonwoven layer 146 may be bonded to an upper surface 154 of the adhesive layer 152. Additionally, the adhesive layer 152 may include a lower surface 156 that includes an adhesive that may be used to secure the tube securement device 100 to the patient's skin 160. Additionally, a release liner 158 may be attached to the underside 156 of the adhesive layer 152 until the tube securement device 100 is to be placed on the patient's skin 160, at which point the release liner 158 may be removed to expose the underside 156 for attachment to the patient's skin 160. Referring now to FIG. 10 , as shown, more than one tube securement device 100 may be used to secure a tube 140 (e.g., a nasoenteric feeding tube) to the patient's skin 160 after a portion of the tube 140 is inserted into an opening 162 (e.g., through the patient's nostril, or any other opening through which a tube may be inserted). The tube securement device 100 allows for an easier, more efficient, safer, and less invasive manner of securing such tubes compared to many currently available products and methods.

[0035] This written specification uses examples to disclose the invention, including the best mode, and also enables any person skilled in the art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they contain structural elements that do not differ from the literal words of the claims, or if they contain equivalent structural elements with differences that are not substantially different from the literal words of the claims.

Claims

1. A tube fixing device, comprising: an upper clamp having an upper surface and a lower surface; a lower clamp having an upper surface and a lower surface; a hinge located between the upper clamp and the lower clamp to define a tube insertion area; A tube clamping device, wherein a ratio of a length of the upper surface of the upper clamp to a length of the lower surface of the lower clamp ranges from about 0.95 to about 1.

20.

2. The tube fixation device of claim 1 , wherein the length of the upper surface of the upper clamp ranges from about 1.25 millimeters to about 1.7 millimeters.

3. 2. The tube fixation device of claim 1, wherein the length of the lower surface of the lower clamp ranges from about 1.2 millimeters to about 1.6 millimeters.

4. 2. The tube securing device of claim 1, wherein the upper surface of the upper clamp and the lower surface of the lower clamp slidably engage when the upper clamp is pressed toward the lower clamp to secure a tube within the tube insertion area.

5. 5. The tube securement device of claim 4, wherein the upper surface of the upper clamp and the lower surface of the lower clamp form an angle with each other in the range of about 0 degrees to about 25 degrees when slidably engaged.

6. The tube clamp device of claim 1 further comprising a protrusion extending from a base of the tube clamp device adjacent the hinge.

7. 2. The tube fixation device of claim 1, wherein the tube insertion region has a radius, and a ratio of the radius of the tube insertion region to an outer diameter of a tube inserted into the tube insertion region ranges from about 1:1 to about 1:

3.

8. The tube securement device of claim 1 , wherein at least one protrusion extends from the lower surface of the upper clamp.

9. 2. The tube securement device of claim 1, wherein the upper surface of the lower clamp includes a first recess at a first edge, a second recess at a second edge, and a raised portion defined therebetween.

10. 2. The tube clamping device of claim 1, wherein the upper surface of the upper clamp and the lower surface of the upper clamp define a trapezoidal shape where the upper surface and the lower surface intersect.

11. 10. The tube clamp device of claim 1, further comprising an intermediate layer having an upper surface and a lower surface, the upper surface of the intermediate layer being attached to the lower surface of the base of the tube clamp device.

12. 12. The tube securement device of claim 11, further comprising a nonwoven layer having an upper surface and a lower surface, the upper surface of the nonwoven layer being attached to the lower surface of the intermediate layer.

13. 13. The tube securement device of claim 12, further comprising an adhesive layer having an upper surface and a lower surface, the upper surface of the adhesive layer being attached to the lower surface of the nonwoven fabric layer.

14. 14. The tube securement device of claim 13, wherein the lower surface of the adhesive layer comprises an adhesive.

15. 14. The tube securement device of claim 13, wherein the lower surface of the adhesive layer is attached to a removable release liner.

16. 10. The tube retainer of claim 1, wherein the tube retainer retains tubes having a size of 6 French, 8 French, 10 French, 12 French, or 14 French.

17. 17. The tube securement device of claim 16, wherein the tube is formed from silicone, polyurethane, polyvinyl chloride, or combinations thereof.

18. The tube securement device of claim 1 , wherein the tube securement device is configured to receive a feeding tube.

19. 20. The tube securement device of claim 18, wherein the tube is a nasoenteral feeding tube.

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